[Federal Register Volume 63, Number 127 (Thursday, July 2, 1998)]
[Rules and Regulations]
[Pages 36177-36178]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-17544]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 97F-0469]


Indirect Food Additives: Adjuvants, Production Aids, and 
Sanitizers

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the food 
additive regulations to provide for the expanded safe use of 
phosphorous acid, cyclic butylethyl propanediol, 2,4,6-tri-tert-
butylphenyl ester, which may contain up to 1 percent by weight of 
triisopropanolamine, as an antioxidant and/or stabilizer in high-
density polyethylene and high-density olefin copolymers intended for 
use in contact with food. This action is in response to a petition 
filed by General Electric Co.

DATES: This regulation is effective July 2, 1998. Written objections 
and requests for a hearing by August 3, 1998.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Vir D. Anand, Center for Food Safety 
and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3081.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of November 20, 1997 (62 FR 62062), FDA announced that a food 
additive petition (FAP 8B4567) had been filed by General Electric Co., 
One Lexan Lane, Mt. Vernon, IN 47620-9364. The petition proposed to 
amend the food additive regulations in Sec. 178.2010 Antioxidants and/
or stabilizers for polymers (21 CFR 178.2010) to provide for the 
expanded safe use of phosphorous acid, cyclic butylethyl propanediol, 
2,4,6-tri-tert-butylphenyl ester, which may contain up to 1 percent by 
weight of triisopropanolamine, as an antioxidant and/or stabilizer in 
high-density polyethylene and high-density olefin copolymers (more 
appropriately identified as high-density polyethylene homopolymers and 
copolymers) intended for use in contact with food.
    FDA has evaluated data in the petition and other relevant material. 
Based on this information, the agency concludes that the proposed use 
of the additive is safe and that the additive will achieve its intended 
technical effect. Therefore, the regulations in Sec. 178.2010 should be 
amended as set forth below.
    In accordance with Sec. 171.1(h) (21 CFR 171.1(h)), the petition 
and the documents that FDA considered and relied upon in reaching its 
decision to approve the petition are available for inspection at the 
Center for Food Safety and Applied Nutrition by appointment with the 
information contact person listed above. As provided in Sec. 171.1(h), 
the agency will delete from the documents any materials that are not 
available for public disclosure before making the documents available 
for inspection.
    The agency has previously considered the environmental effects of 
this rule as announced in the notice of filing for FAP 8B4567 (62 FR 
62062). FDA has concluded that the action is of the type that does not 
individually or cumulatively have a significant effect on the human 
environment, and that therefore, neither an environmental assessment 
nor an environmental impact statement is required.
    Any person who will be adversely affected by this regulation may at 
any time on or before August 3, 1998, file with the Dockets Management 
Branch (address above) written objections thereto. Each objection shall 
be separately numbered, and each numbered objection shall specify with 
particularity the provisions of the regulation to which objection is 
made and the grounds for the objection. Each numbered objection on 
which a hearing is requested shall specifically so state. Failure to 
request a hearing for any particular objection shall constitute a 
waiver of the right to a hearing on that objection. Each numbered 
objection for which a hearing is requested shall include a detailed 
description and analysis of the specific factual information intended 
to be presented in support of the objection in the event that a hearing 
is held. Failure to include such a description and analysis for any 
particular objection shall constitute a waiver of the right to a 
hearing on the objection. Three copies of all documents shall be 
submitted and shall be identified with the docket number found in 
brackets in the heading of this document. Any objection received in 
response to the regulation may be seen in the Dockets Management Branch

[[Page 36178]]

between 9 a.m. and 4 p.m., Monday through Friday.
    This final rule contains no collections of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

List of Subjects in 21 CFR Part 178

    Food additives, Food packaging.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Director, Center for Food Safety and Applied 
Nutrition, 21 CFR part 178 is amended as follows:

PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND 
SANITIZERS

    1. The authority citation for 21 CFR Part 178 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 342, 348, 379e.

    2. Section 178.2010 is amended in the table in paragraph (b) by 
revising the entry for ``Phosphorous acid, cyclic butylethyl 
propanediol, 2,4,6-tri-tert-butylphenyl ester'' by adding item ``4.'' 
under the heading ``Limitations'' to read as follows:


Sec. 178.2010  Antioxidants and/or stabilizers for polymers.

* * * * *
    (b) * * *

                                                                        
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             Substances                          Limitations            
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  *                    *                    *                    *      
                   *                    *                    *          
Phosphorous acid, cyclic butylethyl  For use only:                      
 propanediol, 2,4,6-tri-tert-         * * *                             
 butylphenyl ester (CAS Reg. No.     4. At levels not to exceed 0.1     
 161717-32-4), which may contain      percent by weight of olefin       
 not more than 1 percent by weight    polymers complying with Sec.      
 of triisopropanolamine (CAS Reg.     177.1520(c) of this chapter, items
 No. 122-20-3).                       2.1, 2.2, 2.3, 3.1(a), 3.1(b),    
                                      3.1(c), 3.2 (a), or 3.2(b), having
                                      a density not less than 0.94 grams
                                      per cubic centimeter, in contact  
                                      with foods only of types III, IV, 
                                      V, VI-A, VI-C, VII, VIII, and IX  
                                      identified in Table 1 of Sec.     
                                      176.170(c) of this chapter, and   
                                      under conditions of use B through 
                                      H as described in Table 2 of Sec. 
                                      176.170(c) of this chapter;       
                                      provided that the food-contact    
                                      surface does not exceed 0.003 inch
                                      (0.076 mm) in thickness.          
  *                    *                    *                    *      
                   *                    *                    *          
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    Dated: June 23, 1998.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center 
for Food Safety and Applied Nutrition.
[FR Doc. 98-17544 Filed 7-1-98; 8:45 am]
BILLING CODE 4160-01-F